Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients (ELESDUCCBM)

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Urinary Diversion; Spinal Cord Injuries; Neurogenic Bladder

Treatments: Other: Data collection; Other: Interview using a validated questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04936217

Local 2019/SD-01

Details and patient eligibility

About

Continent Cutaneous Urinary Deviation (CUD), using the Mitrofanoff, Yang-Monti or Casale principle, is offered to patients with neurological diseases who are unable to perform intermittent catheterisation through the native urethra due to upper limb disability.

There is very little data in the literature examining the long-term efficacy and complications of this technique. The main objective of this study is to evaluate the effectiveness of long-term CUDs in spinal cord injury patients. The secondary objectives are to evaluate the surgical complications and the impact on the patient's quality of life.

For each patient, several data will be collected and analyzed: age at operation, sex, Body Mass Index (BMI), ASA score, ASIA score, type of bladder dysfunction assessed by urodynamic evaluation, urinary abnormalities assessed by morphological examination (ultrasound and / or computed tomography) and cystoscopy, creatinine clearance, operative indications, initial mictional mode, surgical assembly and any immediate or late complications. In a second stage, a questionnaire survey will be conducted by telephone.

Enrollment: 70 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Specific inclusion criteria for the study :

• no history of continuous cystostomy in another centre
• a follow-up > 24 months,
• a continent cutaneous urinary diversion for a spinal cord injury.

General inclusion criteria :

• Patient affiliated to or beneficiary of a health insurance scheme.
• Adult patient (≥18 years of age) and under 85 years of age.

Exclusion criteria

• Criteria for non-inclusion specific to the study :
• All urinary incontinence outside of medullary waiting period.
• A history of continuous cystostomy in another centre.
• A follow-up of less than 24 months,
• a continent cutaneous urinary diversion for a neurological pathology other than spinal cord injury.

General criteria for non-inclusion :

• Patient in a period of exclusion determined by another study.
• Patient for whom it is impossible to give enlightened information.
• Patient under legal protection, guardianship or curatorship.
• Patient unable to express consent

Trial design

70 participants in 1 patient group

Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017

Description:

The study focuses of a population of 70 patients operated between April 2004 and October 2017 au Nîmes University Hospital for Cutaneous Urinary Diversion.

Treatment:

Other: Interview using a validated questionnaire

Other: Data collection